Catalog Number

FS+173230BC-G

Brand Name

NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE

Version/Model Number

17GX1-1/4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FIE

Product Code Name

Needle, fistula

Public Device Record Key

56f21143-b4fc-4530-98a8-3b992802ff40

Public Version Date

December 20, 2018

Public Version Number

3

DI Record Publish Date

April 01, 2016

Package DI Number

10383790000281

Quantity per Package

50

Contains DI Package

00383790000284

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton